We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01301001
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Vulvodynia
Interventions: Drug: Placebo oral capsule
Drug: Gabapentin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between August 8, 2012 and January 19, 2016 from three academic centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
230 women were screened, 89 met entry criteria and 66 completed the trial. Of the 141 patients who were excluded prior to randomization, 16 decided not to participate in the trial,101 did not meet inclusion criteria, and 24 did not return for randomization.

Reporting Groups
  Description
Placebo First, Then Gabepentin

Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)

Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm

Gabapentin: Gabapentin 1200 mg am and 1800 mg pm

Gabapentin First, Then Placebo

Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)

Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm

Gabapentin: Gabapentin 1200 mg am and 1800 mg pm


Participant Flow for 3 periods

Period 1:   First Intervention
    Placebo First, Then Gabepentin   Gabapentin First, Then Placebo
STARTED   44   45 
COMPLETED   34   36 
NOT COMPLETED   10   9 
Lost to Follow-up                4                4 
Withdrawal by Subject                1                4 
Adverse Event                5                0 
Protocol Violation                0                1 

Period 2:   Washout (2 Weeks)
    Placebo First, Then Gabepentin   Gabapentin First, Then Placebo
STARTED   34   36 
COMPLETED   34   36 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Placebo First, Then Gabepentin   Gabapentin First, Then Placebo
STARTED   34   36 
COMPLETED   30   36 
NOT COMPLETED   4   0 
Adverse Event                2                0 
Withdrawal by Subject                2                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants 44 subjects were randomized to Placebo First and 45 subjects were randomized to Gabapentin First

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 89 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.54  (2.30) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
 
Female   89 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      58  65.2% 
White      30  33.7% 
More than one race      1   1.1% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   89 


  Outcome Measures

1.  Primary:   Tampon Test Pain Intensity   [ Time Frame: Week 6 for each treatment arm ]

2.  Secondary:   Coital Pain   [ Time Frame: Week 6 of each treatment arm ]

3.  Secondary:   Vulvodynia Pain   [ Time Frame: Week 6 for each treatment arm ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Candace Brown
Organization: University of Tennessee Health Science Center
phone: 9014124341
e-mail: CSBROWN@TENNESSEE.EDU



Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01301001     History of Changes
Other Study ID Numbers: 10-00985-FB CSBrown Vulvodynia
First Submitted: May 13, 2010
First Posted: February 23, 2011
Results First Submitted: August 28, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017